(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Peritoneal carcinomatosis | Colorectal cancer | Gastric cancer | Ovarian cancer | Pancreatic ductal adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Participant is ≥18 years of age\n- Participant has provided signed informed consent before any study-specific screening procedures\n- Participant has histopathologically confirmed primary colorectal, gastric or ovarian cancer or PDAC\n- Participant has known or suspected PC from the tumor of origin. Suspicion may be based on imaging or clinical findings\n- Participant is scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy, with either: a. No neoadjuvant treatment received, treatment-naïve (i.e., undergoing upfront surgery or laparoscopy) b. Completed systemic treatment (which may include neoadjuvant chemotherapy) before GEH300079 (68Ga) PET/CT Imaging Visit\n- Participant has Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n- Participant is able and willing to comply with all study procedures as described in the protocol"}

Exclusion criteria

• {"criterion_text":"- Participant is pregnant or breast-feeding, or sexually active and not using or not willing to use an acceptable form of birth control from at least 30 days before the screening visit until 30 days after receiving the investigational medicinal product (IMP)\n- Participant has a known disorder that, in the opinion of the investigator, will impact the study procedures\n- Participant needs any intervention that would delay study participation\n- Participant has non-resectable extra-abdominal metastasis and/or >3 hepatic metastases on standard workup\n- Participant will not be able to complete the study, based on their anticipated life expectancy\n- Participant has active bacterial, viral, or fungal infection requiring systemic antibacterial, anti-viral or antifungal therapy (topical medications are permitted)\n- Participant has renal function impairment as defined by: a. For Phase 2: estimated glomerular filtration rate less than 60 mL/min b. For Phase 3: estimated glomerular filtration rate less than 30 mL/min\n- Participant has severe hepatic function impairment as defined by either: a. Aspartate aminotransferase or alanine aminotransferase: >5 × upper limit of normal (ULN); or b. Total bilirubin >3 × ULN\n- Participant has Crohn’s disease, ulcerative colitis, or sarcoidosis\n- Participant has serious co-morbidities or serious non-malignant disease that in the opinion of the investigator, could compromise participant safety and/or protocol objectives\n- Participant either received or is planning to receive any other investigational agent within the 28 days prior to the first imaging visit or during study participation (with the exception of the 3-month follow-up period)\n- Participant has known or suspected hypersensitivity to any excipients used in GEH300079 (68Ga)\n- Participant has severe claustrophobia, is unable to lie flat or fit into the scanner, or is unable to tolerate the PET/CT scan for any reason\n- (Phase 3 only) Participant was previously included in Phase 2 of this study"}

Primary endpoints

• {"endpoint_text":"- Phase 2 Efficacy Endpoints: Co-Primary Endpoints: • Per-region sensitivity of GEH300079 (68Ga) PET/CT imaging to detect PC, superior to a pre-specified threshold of 75% and • Per-region specificity of GEH300079 (68Ga) PET/CT imaging to detect PC, superior to a pre-specified threshold of 70%","definition_or_measurement_approach":"Per-region sensitivity and specificity of GEH300079 (68Ga) PET/CT for detection of peritoneal carcinomatosis; compared to pre-specified thresholds (sensitivity >75%, specificity >70%)."}
• {"endpoint_text":"- Phase 2 Exploratory Endpoints: • SUVmean and SUVmax thresholds that best discriminate Positive and Negative PC lesions • Detection of primary lesions per participant by GEH300079 (68Ga) PET/CT as compared to baseline SoC imaging, based on on-site read","definition_or_measurement_approach":"Exploratory analysis to identify SUVmean and SUVmax thresholds; detection of primary lesions per participant compared to baseline standard of care imaging (on-site read)."}
• {"endpoint_text":"- Phase 2 Exploratory Endpoints: • Number of organs/anatomic structures with potential extra-PC metastases (including involvement in viscera, bones, lymph nodes) identified on GEH300079 (68Ga) PET/CT and baseline SoC imaging per participant, and percentage of participants with at least 1 organ/anatomic structure with potential extra-PC metastases identified by GEH300079 (68Ga) PET/CT scan as compared to baseline SoC imaging, based on on-site read","definition_or_measurement_approach":"Count of organs/anatomic structures with potential extra-PC metastases identified by GEH300079 (68Ga) PET/CT and baseline SoC imaging; percentage of participants with ≥1 such organ identified by GEH300079 compared to SoC (on-site read)."}
• {"endpoint_text":"- Phase 2 Safety Endpoints: Adverse events: • Incidence of treatment-emergent AEs (TEAEs) by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term (PT) Urinalysis and clinical laboratory parameters: • Observed values and changes from baseline • Occurrence of changes from baseline values of >40% and >80% of the span of the normal limits • Occurrence of post-administration values outside the normal limits","definition_or_measurement_approach":"Safety assessed by incidence of TEAEs by MedDRA SOC and PT; urinalysis and lab parameters evaluated by observed values, changes from baseline, and specified thresholds (>40% and >80% of span of normal limits) and out-of-range post-administration values."}
• {"endpoint_text":"- Phase 2 Safety Endpoints: Vital signs (BP, RR, HR, body temperature): • Observed values and changes from baseline • Occurrence of changes from baseline greater than a pre-specified magnitude (20 mmHg for systolic BP, 10 mmHg for diastolic BP, 10 beats per minute for HR, 10 breaths per minute for RR, 1.5°C for body temperature) • Occurrence of post-administration values outside the normal limits","definition_or_measurement_approach":"Vital signs measured and compared to baseline; specified change thresholds define events of interest; also monitor for post-administration values outside normal limits."}
• {"endpoint_text":"- Phase 2 Safety Endpoints: Electrocardiography: • Observed values and changes from baseline • Occurrence of changes from baseline within the following pre-specified increments: • Increments of 4 ms (<4, ≥4 to ≤8, >8 to ≤12, and >12 ms), 10 ms (<10, ≥10 to ≤20, and >20 ms) and 25 ms (<25, ≥25 to ≤50, and >50 ms) for PR interval • <30 ms, ≥30 to ≤60 ms, and >60 ms increments for QTcF interval","definition_or_measurement_approach":"ECG intervals (PR, QTcF) measured and categorized by pre-specified increment ranges to assess changes from baseline."}
• {"endpoint_text":"- Phase 2 Safety Endpoints: Electrocardiography: • <50 ms, ≥50 to ≤100 ms, and >100 ms increments for QRS interval • <250 ms, ≥250 to ≤500 ms, and >500 ms increments for RR interval • Occurrence of post-administration values outside the normal limits in the PR, QTc, QRS or RR interval • Overall interpretation at each post-administration time point Physical examination: • Occurrence of changes from baseline in physical examination status (normal/abnormal)","definition_or_measurement_approach":"ECG QRS and RR intervals categorized by specified increments; monitor for out-of-range values in ECG intervals; physical exam changes from baseline recorded."}
• {"endpoint_text":"- Phase 3: Efficacy Endpoints: • Per-region sensitivity of GEH300079 (68Ga) PET/CT imaging for the detection of PC, superior to a prespecified threshold of 75% and • Per-region specificity of GEH300079 (68Ga) PET/CT imaging for the detection of PC, superior to a prespecified threshold of 70%","definition_or_measurement_approach":"Per-region sensitivity and specificity in Phase 3 compared to prespecified thresholds (sensitivity >75%, specificity >70%)."}
• {"endpoint_text":"- Phase 3: Exploratory Endpoints: • SUVmean and SUVmax thresholds that best discriminate Positive and Negative PC lesions • Detection of primary lesions per participant by GEH300079 (68Ga) PET/CT as compared to baseline SoC imaging, based on on-site read","definition_or_measurement_approach":"Exploratory SUV threshold analyses and per-participant detection of primary lesions versus baseline SoC imaging (on-site read)."}
• {"endpoint_text":"- Phase 3: Exploratory Endpoints: • Number of organs/anatomic structures with potential extra-PC metastases (including involvement in viscera, bones, lymph nodes) identified on GEH300079 (68Ga) PET/CT and baseline SoC imaging per participant, and percentage of participants with at least 1 organ/anatomic structure with potential extra-PC metastases identified by GEH300079 (68Ga) PET/CT scan as compared to baseline SoC imaging, based on on-site read","definition_or_measurement_approach":"Count and percentage of organs/anatomic structures with potential extra-PC metastases identified by GEH300079 PET/CT versus baseline SoC imaging (on-site read)."}
• {"endpoint_text":"- Phase 3: Safety Endpoints: AEs: • Incidence of TEAEs by MedDRA system organ class and PT Urinalysis and clinical laboratory parameters: • Observed values and changes from baseline • Occurrence of changes from baseline values of >40% and >80% of the span of the normal limits • Occurrence of post-administration values outside the normal limits","definition_or_measurement_approach":"Safety endpoints measured by TEAE incidence and laboratory/urinalysis changes as specified (>40% and >80% thresholds and out-of-range values)."}
• {"endpoint_text":"- Phase 3: Safety Endpoints: Vital signs (BP, RR, HR, body temperature): • Observed values and changes from baseline • Occurrence of changes from baseline greater than a pre-specified magnitude (20 mmHg for systolic BP, 10 mmHg for diastolic BP, 10 beats per minute for HR, 10 breaths per minute for RR, 1.5°C for body temperature)","definition_or_measurement_approach":"Vital signs monitored with predefined change thresholds to identify significant changes from baseline."}
• {"endpoint_text":"- Phase 3: Safety Endpoints: Vital signs (BP, RR, HR, body temperature): • Occurrence of post-administration values outside the normal limits Physical examination: • Occurrence of changes from baseline in physical examination status (normal/abnormal)","definition_or_measurement_approach":"Monitoring for post-administration vital signs outside normal limits and physical exam changes from baseline."}

Secondary endpoints

• {"endpoint_text":"- Phase 2: Efficacy Endpoints: Co-key Secondary Endpoints: I. Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging (i.e., CT, MR, or [18F]FDG PET/CT) and II. Non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging","definition_or_measurement_approach":"Compare per-region sensitivity (superiority) and specificity (non-inferiority) of GEH300079 PET/CT versus baseline SoC imaging modalities."}
• {"endpoint_text":"- Phase 3: Efficacy Endpoints: Co-Key Secondary Endpoints: I. Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging (i.e., CT, MR or [18F]FDG PET/CT) and II. Non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging","definition_or_measurement_approach":"Compare per-region sensitivity (superiority) and specificity (non-inferiority) of GEH300079 PET/CT versus baseline SoC imaging modalities in Phase 3."}

Sweden

Earliest CTIS Part Ii Submission Date

13-02-2026

Latest Decision Or Authorization Date

25-02-2026

Processing Time Days

12

Number Of Sites

1

Number Of Participants

5

Primary sponsor

Full Name

GE Healthcare Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

United Kingdom

Contract research organisations

Name

Fortrea Inc.

Responsibilities

Site Startup; Clinical Ancillary Supplies Services; Clinical Monitoring; Pharmacokinetics; other sponsorDuties codes listed in submission

Name

Medidata Solutions Inc.

Responsibilities

Electronic Data Capture (EDC) and associated services

Third parties

• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,15 (value: 'Site Startup; Clinical Ancillary Supplies Services; Clinical Monitoring; Pharmacokinetics'),5,6,7,8; contact email: submissions@fortrea.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 15 (value: 'EDC'),7; contact email: helpdesk@mdsol.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Welocalize Inc.","duties_or_roles":"sponsorDuties code: 15 (value: 'Translation services'); contact email: LP_GLS@welocalize.com","organisation_type":"Pharmaceutical company"}